Initiator Pharma A/S, a biotech company that is developing a novel treatment of erectile dysfunction today announced successful completion of dosing af healthy subject in the Phase 1 clinical trial.
The Phase 1 trial, randomized, double-blind, placebo controlled single ascending dose in multiple cohorts of healthy subjects, has now been completed and we have reached expected clinically relevant dose levels. The preliminary readout from the phase 1 has demonstrated that IPED2015 in general is safe and well tolerated.
‘We are very pleased with the completion of the Phase 1 trial. We are looking forward to initiate the Phase 2a trial for IPED2015, where we hope to demonstrate efficacy in Erectile dysfunction (ED) patients and generate the Proof-of-Concept (cPoC) that will support the ongoing efforts to enter a deal setting with IPED2015’ says CEO, Claus Elsborg Olesen
The final preparations of the Phase 2a/cPoC study in ED patients is currently being completed and the intend is to start the first treatments in approx. 3-4 weeks pending the recruitment of patients suffering from ED. The aim is to complete the clinical phase of this study over the summer and initiate data analysis right after that.
For additional information about Initiator Pharma, please contact:
Claus Elsborg Olesen, CEO
Telephone: +45 6126 0035 E-mail: firstname.lastname@example.org
This information is the information that Initiator Pharma is required to disclose under the EU Market Abuse Regulation. The information was provided under the above contact person’s auspices, for publication on June 10th, 2019.
About Initiator Pharma
Initiator Pharma is a Biotech company established in Aarhus, Denmark. Its main asset IPED2015 represents a novel treatment paradigm for the treatment of Erectile Dysfunction (ED) and will improve the quality of life for the growing number for patients (and their partners) that do not respond or cannot be treated with the current marketed medication.
About Erectile dysfunction
Erectile dysfunction is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual activity. ED affects more than 150 million men worldwide and that number is expected to increase to more than 320 million by 2025, fueled by aging demographics and increasing prevalence of life style diseases such as diabetes. ED patients have decreased quality of life due to various psychosocial factors such as low self-esteem, depression, sadness, anger, frustration, anxiety, and relationship problems (1,2, 3).
1. Shabsigh R, et al. (1998) Increased incidence of depressive symptoms in men with erectile dysfunction. Urology52(5):848–852.
2. Mccabe MP, Althof SE (2014) A systematic review of the psychosocial outcomes associated with erectile dysfunction: Does the impact of erectile dysfunction extend beyond a man’s inability to have sex? J Sex Med11(2):347–363.
3. Nguyen HMT, Gabrielson AT, Hellstrom WJG (2017) Erectile Dysfunction in Young Men—A Review of the Prevalence and Risk Factors. Sex Med Rev5(4):508–520.